Summary
The FDA issued a Class II for 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 by Acumed LLC. Reason: Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting.
Details
Source
Device Recall
External ID
Z-0959-2022
Action Date
2022-04-27
Status
Completed
Category
device
Product Description
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
Lot/Code Info: All Batch numbers distributed between 22 AUG 2018 to 07 FEB 2022. UDI:10806378022876
Quantity Affected: 506 unit
Reason for Recall
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and the country of South Africa.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-09
Company
Hillsboro, OR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Acumed LLC has 17 FDA actions in our database, including 8 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Acumed LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Acumed LLC have FDA actions?
Acumed LLC has 17 FDA actions in our database, including 8 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0959-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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